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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036677
Receipt No. R000041699
Scientific Title Association between carperitide infusion and shedding of the endothelial glycocalyx in cardiac surgical patients
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/08

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Basic information
Public title Association between carperitide infusion and shedding of the endothelial glycocalyx in cardiac surgical patients
Acronym Carperitide infusion and shedding of the endothelial glycocalyx in cardiac surgical patients
Scientific Title Association between carperitide infusion and shedding of the endothelial glycocalyx in cardiac surgical patients
Scientific Title:Acronym Carperitide infusion and shedding of the endothelial glycocalyx in cardiac surgical patients
Region
Japan

Condition
Condition Postoperative cardiac surgery patients recieving carperitide infusion therapy
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients who start to receive carperitide infusion, parameters of sublingual microcirculation SDF-imaging analysis including Perfused Boundary Region (PBR), and plasma syndecan-1 concentration will be measured over time to investigate the shedding of glycocalyx associated to carperitide infusion.
Basic objectives2 Others
Basic objectives -Others Shedding of endothelial glycocalyx associated to carperitide infusion.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change in Perfused Boundary Region (PBR) [Time frame: just before the start of carperitide infusion, 1h, 2h, 6h after the start of infusion]
Key secondary outcomes Change in plasma syndecan-1 concentration, RBC column width, RBC filling [Time frame: just before the start of carperitide infusion, 1h, 2h, 6h after the start of infusion]

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Postcardiac surgery patients who scheduled to start carperitide infusion therapy in the intensive care unit.
Key exclusion criteria 1.A patient who have had recieved carperitide infusion within 12h
2.A patient with wobbly tooth
3.A patient who have surgical history of tongue
4.A patient without any indwelling arterial line
5.A patient determined to be inappropriate as a research subject by the principal investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Saitoh
Organization Hokkaido University Hospital
Division name Anesthesiology, ICU
Zip code 060-8648
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Email kazuyuki_mizunoya@hotmail.com

Public contact
Name of contact person
1st name Kazuyuki
Middle name
Last name Mizunoya
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code 060-8648
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email kazuyuki_mizunoya@hotmail.com

Sponsor
Institute Hokkaido University Hospital
Anesthesiology, ICU
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Division of Clinical Research Administration
Address Kita 14, Nishi 5, Kita-ku, Sapporo
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2019 Year 05 Month 08 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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